Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation
Public ClinicalTrials.gov record NCT04203316. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label Feasibility Study to Assess the Safety and Pharmacokinetics of Enasidenib in Pediatric Patients With Relapsed/Refractory Acute Myeloid Leukemia (R/R-AML) With an Isocitrate Dehydrogenase-2 (IDH2) Mutation
Study identification
- NCT ID
- NCT04203316
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Children's Oncology Group
- Network
- Enrollment
- 1 participant
Conditions and interventions
Interventions
- Biospecimen Collection Procedure
- Bone Marrow Aspiration Procedure
- Bone Marrow Biopsy Procedure
- Enasidenib Drug
- Enasidenib Mesylate Drug
Procedure · Drug
Eligibility (public fields only)
- Age range
- 24 Months to 21 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 13, 2023
- Primary completion
- Sep 29, 2025
- Completion
- Oct 2, 2026
- Last update posted
- Jan 8, 2026
2023 – 2026
United States locations
- U.S. sites
- 27
- U.S. states
- 20
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202-3591 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado | 80218 | — |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| UF Health Cancer Institute - Gainesville | Gainesville | Florida | 32610 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | 60611 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | — |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Saint Jude Children's Research Hospital | Memphis | Tennessee | 38105 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| Children's Hospital of San Antonio | San Antonio | Texas | 78207 | — |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04203316, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 8, 2026 · Synced May 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04203316 live on ClinicalTrials.gov.